The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Deep Freeze System (dfs-30).
| Device ID | K760953 |
| 510k Number | K760953 |
| Device Name: | DEEP FREEZE SYSTEM (DFS-30) |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | SPEMBLY MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-02 |
| Decision Date | 1976-11-16 |